fentanyl transdermal (skin patch)

What is the most important information I should know about a this medicine?

Fentanyl can slow or stop your breathing. MISUSE OF FENTANYL TRANSDERMAL CAN CAUSE DEATH, especially in a child who gets a hold of the skin patch and places it in the mouth or on the skin.

Fentanyl may be habit-forming, and the transdermal skin patch contains a high concentration of this medicine. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

Do not use a fentanyl skin patch if you have a breathing problem, a blockage in your stomach or intestines, or if you are NOT already being treated with a similar opioid (narcotic) pain medicine and are tolerant to it. You may not be able to use fentanyl transdermal if you also use certain antibiotics, antifungal medications, heart or blood pressure medications, or medicines to treat HIV or AIDS. Tell your doctor about all medicines you use.

Avoid sources of heat while you are wearing a fentanyl skin patch. Heat can increase the amount of drug your skin absorbs.

What is fentanyl transdermal skin patch?

Fentanyl is an opioid pain medication. An opioid is sometimes called a narcotic.

The fentanyl skin patch is used to treat moderate to severe chronic pain around the clock. Fentanyl transdermal is not for treating mild or occasional pain or pain from surgery.

Fentanyl transdermal may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using a fentanyl transdermal skin patch?

Fentanyl may be habit-forming, and the transdermal skin patch contains a high concentration of this medicine. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Selling or giving away fentanyl is against the law.

Do not use a fentanyl skin patch if you are allergic to fentanyl, or if you have:

a severe breathing problem such as asthma attacks;

a blockage in your digestive tract (stomach or intestines); or

if you are NOT already being treated with a similar opioid (narcotic) pain medicine and are tolerant to it.

Some medicines can cause unwanted or dangerous effects when used with fentanyl transdermal. You may not be able to use this medicine if you also use certain antibiotics, antifungal medications, heart or blood pressure medications, or medicines to treat HIV or AIDS. Tell your doctor about all medicines you use.

To make sure fentanyl transdermal is safe for you, tell your doctor if you have:

any type of breathing problem or lung disease;

a history of head injury, brain tumor, or mental illness;

a history of alcoholism or drug addiction;

a fever;

urination problems;

liver or kidney disease; or

problems with your gallbladder, pancreas, or thyroid.

Fentanyl transdermal should not be used on a child younger than 2 years old. Do not put a fentanyl skin patch on any child who does not have a personal prescription for this medicine.

FDA pregnancy category C. It is not known whether fentanyl transdermal will harm an unborn baby. Fentanyl may cause breathing problems, behavior changes, or addiction and withdrawal symptoms in your newborn if you use the medication during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant.

Fentanyl can pass into breast milk and may also cause addiction and withdrawal symptoms in a nursing infant. Do not breast-feed while using fentanyl transdermal.

The fentanyl skin patch may burn your skin if you wear the patch during an MRI (magnetic resonance imaging). Remove the patch before undergoing such a test.

How should I use fentanyl transdermal skin patches?

Follow all directions on your prescription label. Never use this medicine in larger amounts, or for longer than prescribed. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

MISUSE OF FENTANYL TRANSDERMAL CAN CAUSE HARMFUL SIDE EFFECTS OR DEATH, especially in a child who gets a hold of the skin patch and places it in the mouth or on the skin. Read all patient instructions carefully before using a fentanyl skin patch.

Do not use this medicine on a child who does not have a prescription to use fentanyl transdermal. When placing a skin patch on a young child, choose a wearing area where the child cannot easily remove the patch unsupervised.

Do not use a skin patch if it has been cut or damaged, or you could receive a fatal overdose of fentanyl.

A fentanyl skin patch is for use only on the skin. Avoid touching the sticky side of a skin patch. Wash your hands after applying a skin patch. Do not allow the medicine to come into contact with your eyes, nose, mouth, or lips.

Apply the patch to a flat area of the chest, back, side, or outer side of your upper arm. Trim body hair with scissors but do not shave patch-wearing areas. Clean the skin only with clear water, and dry completely. Press the patch firmly with the palm of your hand for 30 seconds. Check the patch often, to make sure it is firmly on your skin at all times.

Avoid sources of heat while you are wearing the patch. Do not use a heating pad or electric blanket, a waterbed heater, tanning bed or sauna. Do not sit in hot water, sunbathe, or raise your body temperature with vigorous activity. Heat can increase the amount of drug you absorb through your skin and may cause an overdose or death.

Remove and replace the patch every 72 hours. Apply the new patch to a different skin area on the chest, back, side, or upper arm. After removing a skin patch: fold it in half firmly with the sticky side in, and flush the patch down the toilet right away. Do not place a used skin patch into a trash can. Also flush any unused skin patches in the same folded manner when you no longer need this medicine. Do not flush the foil pouch or patch liners; place them in a trash container out of the reach of children and pets.

Keep both used and unused fentanyl skin patches out of the reach of children or pets. The amount of fentanyl in a used skin patch could be fatal to a child or pet who accidentally chews, sucks on, or swallows the patch. Seek emergency medical attention if this happens.

Store the skin patches at room temperature. Keep each patch in its foil pouch until you are ready to use it. Keep track of how many skin patches have been used from each new package. Fentanyl is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

What happens if I miss a dose?

If you are using the skin patches on a schedule, apply the missed patch as soon as you remember. Continue wearing the patch for up to 72 hours and then apply a new one if needed for pain. Do not wear extra patches to make up a missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A fentanyl overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include slow breathing and heart rate, severe drowsiness, muscle weakness, cold and clammy skin, pinpoint pupils, and fainting.

What should I avoid while using a fentanyl transdermal patch?

This medication may impair your thinking or reactions. Do not drive or operate machinery until you know how fentanyl will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Do not drink alcohol or dangerous side effects and death could occur. Check your food and medicine labels to be sure these products do not contain alcohol.

Avoid wearing a skin patch on a part of your body where a child could reach or remove the patch from your skin. Avoid allowing children to watch you put on a skin patch. Never tell a child that the fentanyl skin patch is a "bandage."

What are the possible side effects of a fentanyl transdermal skin patch?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Remove the skin patch and call your doctor at once if you have:

slow heart rate, sighing, weak or shallow breathing (can occur up to 3 days or longer after removing the skin patch);

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect fentanyl transdermal?

Using this medicine with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before using fentanyl transdermal with a sleeping pill, a sedative or tranquilizer, other narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

You should not use fentanyl transdermal if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Other drugs may interact with fentanyl transdermal, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all your medications and any you start or stop using during treatment with fentanyl transdermal.

Where can I get more information?

Your doctor or pharmacist can provide more information about fentanyl transdermal.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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